EN ISO 11138-4:2017
Current
The latest, up-to-date edition.
Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes (ISO 11138-4:2017)
29-03-2017
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) - Method for determination of
resistance to dry heat sterilization
Annex B (normative) - Calculation of z value
Bibliography
Describes requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 degrees C to 180 degrees C.
| Committee |
CEN/TC 102
|
| DevelopmentNote |
Supersedes EN 866-6. (07/2006)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| SN EN ISO 11138-4 : 2017 | Identical |
| PN EN ISO 11138-4 : 2017 | Identical |
| BS EN ISO 11138-4:2017 | Identical |
| NBN EN ISO 11138-4 : 2006 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| UNI EN ISO 11138-4 : 2006 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| DIN EN ISO 11138-4:2017-07 | Identical |
| SS-EN ISO 11138-4 : 2017 | Identical |
| ISO 11138-4:2017 | Identical |
| NF EN ISO 11138-4 : 2017 | Identical |
| UNI EN ISO 11138-4 : 2017 | Identical |
| VDI 6300 Blatt 1:2016-05 | Genetic engineering operations in genetic engineering facilities - Guidance on safe operation of genetic engineering facilities |
| ISO 18472:2006 | Sterilization of health care products Biological and chemical indicators Test equipment |
| ISO 20857:2010 | Sterilization of health care products Dry heat Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 11138-1:2017 | Sterilization of health care products — Biological indicators — Part 1: General requirements |
| ISO 14161:2009 | Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results |
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